DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 2 recites the limitation “the sensing signal is replaced with one of signals comprising” in Ln. 1-2 which deems the claim indefinite. It is unclear what is intended by the recitation of the sensing signal as being “replaced”. Is the inhaled air sensor no longer sensing in the same manner and instead sensing a different parameter? Is operation of the drug fine particle generator instead using a different signal for input? It appears applicant may be intending to claim that the operation of the drug fine particle generator can be alternately controlled based on a signal from the sensing options recited by the instant claim instead of only specifically the inhaled air sensor of claim 1. If so, that language should be made clear in the claim. Applicant is also reminded that requirements of a prior apparatus claim cannot be removed in a dependent claim without causing a rejection under 35 U.S.C. 112(d). For the purposes of examination the claim will be examined as required one of the signals recited by the claim, but at present that additional signal has not been clearly linked to control of the drug fine particle generator.
Claim 2 recites a variety of possible signals in options 2-5 of the claim without reciting any structure to acquire those respective signals. The claim thus improperly attempts in its options 2-5 to recite the apparatus based on what it does rather than what it is (see MPEP 2173.05(g)). Each of options 2-5 should be amended to recite a structure, most likely a sensor, which is suitable to provide the signal recited in those options (such as the chest sensor recited in option 1 of the claim).
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “heating and humidifying apparatus being configured to generate second air by adjusting a temperature and a humidity of the first air” in claim 1 and “fine particle generating element” in claim 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for the heating and humidifying apparatus is best understood from the specification as at least: heating and humidifying apparatus 3 in the form of a heating humidifier common in the art (e.g. Fig. 1).
The corresponding structure for the fine particle generating element is best understood from the specification as at least: fine particle generating element 34 which performs ultrasonic vibration (e.g. ¶¶25 & 27).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (U.S. Pub. 2013/0014759) in view of Smaldone (U.S. Pub. 2021/0236750) and further in view of Parker et al. (U.S. Pub. 2007/0157931).
Regarding claim 1, Montgomery discloses an aerosol drug supply apparatus (Fig. 1; ¶0025) for a respirator (¶0025), the aerosol drug supply apparatus comprising: an air purifier (Fig. 1 #1; ¶0025) configured to discharge first air in which an oxygen concentration, a pressure, and a speed thereof are set (¶0028 – delivered air has some oxygen in it, positive pressure, air has some flow rate); a first tube (Fig. 1 between #1 and #4) along which the first air moves; a humidifying apparatus (Fig. 1 #4; ¶0025) connected to the first tube, the humidifying apparatus being configured to generate second air by a humidity of the first air (¶¶0025, 0037), and the humidifying apparatus being configured to discharge the second air; a second tube (Fig. 1 between #4 and #5) which is connected to the humidifying apparatus and along which the second air moves; a T-tube (Fig. 1 at #5) having a straight tube (Fig. 1 inline with inspiration flow) that has one side thereof provided with a branch tube (Fig. 1 to which nebulizer 5 is attached; ¶¶0025, 0036), the straight tube being connected to the second tube (Fig. 1), thereby allowing the second air to pass therethrough; a drug fine particle generator (Fig. 1 #5; ¶¶0025, 0036) mounted on the branch tube, and the drug fine particle generator being configured to spray a drug in a fine particle state to the second air (¶¶0035-0037); a Y-tube (Fig. 1 connecting inspiratory limb and expiratory limb to #6), the Y-tube having another side connected to a mask or a mouthpiece (¶0038 – endotracheal tubing is readable on a mouthpiece); and a return tube (Fig. 1 #3; ¶0025) having one side connected to the Y-tube (Fig. 1), the return tube having another side connected to the air purifier (Fig. 1), thereby allowing exhaled air to flow therethrough. It is noted that the “air purifier” is not expressly recited as either including any structure which performs purifying or as functionally performing any purifying of air. Thus, the term “purifier” is only understood as intended functionality and is given limited patentable weight (see MPEP 2114).
Montgomery fails to disclose an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air and to generate a sensing signal; and the drug fine particle generator being configured to be operated only when the sensing signal is input. Montgomery fails to explicitly disclose the humidifying apparatus also performs heating; and the Y-tube having one side connected to the T-tube.
The illustration of Fig. 1 of Montgomery shows an additional piece of tubing between in-line nebulizer 5 and the wye piece, which means they are not “connected” in the illustration. However, Montgomery teaches it is preferred to locate the nebulizer proximate to the patient near the wye piece (¶0028). One of ordinary skill in the art would thus have considered it prima facie obvious to have specified in Montgomery the in-line nebulizer 5 as connected to the wye piece as fulfilling a preferred intention of Montgomery to locate the nebulizer as close to the patient as possible while still maintaining the nebulizer in a position upstream of the wye piece (e.g. ¶0028 and Fig. 1).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the Y-tube having one side connected to the T-tube in order to provide the benefit of locate the drug fine particle generator (i.e. the nebulizer of Montgomery) as close to the patient as possible while still maintaining the drug fine particle generator in a position upstream of the Y-tube in view of the preference of this type of positioning as taught by Montgomery.
Smaldone teaches a ventilator circuit including a nebulizer (e.g. Figs. 1 & 5; ¶¶0034, 0048) including an inhaled air sensor (Figs. 1 & 5 #114; ¶0037) connected to a ventilator (Figs. 1 & 5 #102; ¶0037), the inhaled air sensor being configured to sense air exiting the ventilator and to generate a sensing signal (¶0037); and a nebulizer (Figs. 1 & 5 #101; ¶0037) being configured to be operated only when the sensing signal is input (¶0037 – nebulizer turned off when inhalation phase no longer detected). Smaldone teaches an inhaled air sensor controlling operation of a nebulizer as providing the benefit of synchronizing nebulizer delivery to only occur upon breath-actuation (¶¶0037-0039). It is additionally noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Montgomery an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air and to generate a sensing signal; and the drug fine particle generator being configured to be operated only when the sensing signal is input in order to provide the benefit of controlling operation of the drug fine particle generator (i.e. the nebulizer of Montgomery) to only delivery nebulized drug upon breath-actuation in view of Smaldone.
Parker teaches a ventilator circuit including a nebulizer (Fig. 2; ¶¶0077, 0080) and teaches the circuit used with a humidifier obviously controlled to provide heating to its humidified air (¶0170 – different temperatures of gases delivered). One of ordinary skill in the art would have obviously recognized that heating is a common function of humidifiers in the respiratory art as heating of the humidified gas helps ensure patient comfort by providing the humidified gas close to a normal physiological temperature.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the humidifying apparatus also performs heating in order to provide the benefit of heating the humidified air to help ensure patient comfort by providing the humidified air close to a normal physiological temperature both in view of Parker and the common use of humidifiers in the respiratory art.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (U.S. Pub. 2013/0014759) in view of Smaldone (U.S. Pub. 2021/0236750) and further in view of Parker et al. (U.S. Pub. 2007/0157931) and further in view of Porter et al. (U.S. Pub. 2018/0272081).
Regarding claim 2, Montgomery teaches the invention as modified above but fails to teach the sensing signal is replaced with one of signals comprising: 1) a signal generated when a chest sensor is mounted on a patient's chest and the chest sensor detects when the patient's chest expands; 2) a specific brain wave signal generated when the patient is breathing; 3) a signal generated by detecting an air flow of inhaled air in the mask or the mouthpiece; 4) a signal generated by detecting an air pressure of the inhaled air in the mask or the mouthpiece; and 5) a signal generated by detecting an air temperature of the inhaled air in the mask or the mouthpiece.
Porter teaches an aerosol delivery system (Fig. 2; ¶0031) including breath sensors (Fig. 2 #34; ¶0033) to control aerosol delivery based on a patient’s breath cycle (¶0033) which can take various forms, to include an impedance plethysmography sensor (Fig. 3 #40; ¶0035). One of ordinary skill in the art would recognize the impedance plethysmography sensor 40 of Fig. 3 as being a chest sensor which detects when the patient's chest expands. Porter thus teaches a chest sensor as an obvious design choice option of a breath sensor known in the art to be usable for controlling aerosol delivery based on a patient’s breath cycle.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Montgomery a signal generated when a chest sensor is mounted on a patient's chest and the chest sensor detects when the patient's chest expands in order to provide the benefit of adding an additional form of breath sensor known in the art to be usable for controlling aerosol delivery based on a patient’s breath cycle in view of Porter.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, Montgomery fails to teach or suggest the overall requirements of the drug fine particle generator including all elements recited by the instant claim. Montgomery does teach use of a known PARI in-line nebulizer (¶¶0024, 0036, 0039, 0041-0047, 0052) but does not discuss the particular details of that nebulizer. Specifically, Montgomery fails to teach or suggest a packing closure which is mounted on the cover and in which a packing having elasticity is disposed, and the drug is injected into the medication case by piercing the packing with a syringe needle.
Two prior art which illustrate the state of the art in terms of nebulizer reservoirs are Clancy et al. (U.S. Pub. 2009/0241948) and Gallem et al. (U.S. Pub. 2011/0146670).
Clancy teaches a nebulizer (Fig. 1(a) #2 shown exploded in Fig. 4; ¶0074) including a removable plug 401 (Fig. 14; ¶0097). The function of the removable plug 401 is to securely close the nebulizer reservoir 1 during use and then to be openable to allow introduction of liquid from a syringe or other suitable delivery means (¶0097; e.g. Figs. 5, 12 & 14). Thus, Clancy has no concern with keeping the nebulizer reservoir 1 sealed during refilling and even designs opening 400 to receive a syringe when the removable plug 401 is removed, instead of the claimed piercing of the packing with a syringe needle to effect refilling.
Gallem teaches a nebulizer (e.g. Figs. 4 & 7 #14) having a fluid container 14 including a screw threaded lid 18 which is removed when refilling of the fluid container 14 is required (¶0036). Gallem specifically teaches its design as suitable to maintain positive pressure during filling (¶¶0007, 0014) while also teaching it is common to interrupt nebulization briefly in order for filling to occur (¶0006).
There is thus not found to be any reasonable expectation in Clancy or Gallem (or any other directly related prior art) which would have suggested modifying Montgomery in order to specifically include an elastic packing on the cover to be pierced with a syringe needle to effect refilling. Rather, both Clancy and Gallem express the clear expectation of one of ordinary skill in the art that refilling would be expected to occur by removal of a cap, and with no deleterious effects from that cap removal.
Given the particular liquid reservoir and nebulizer design of Montgomery, Clancy and Gallem there is not found to be a preponderance of the evidence that one of ordinary skill in the art would have considered it prima facie obvious to have modified any of those references in order to have arrived at the instantly claimed invention without improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785